A Phase II Study of Axitinib in Metastatic Non-clear Cell Renal Cell Carcinoma Patients Previously Treated With Temsirolimus

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

• 1. There is no standard treatment option for non-clear cell renal cell carcinoma (RCC).

• 2. Patients with non-clear cell RCC is strongly assumed to have benefit from anti-VEGF treatment.

• 3. There is no trial of axitinib for non-clear cell RCC.

• 4. Axitinib is expected to show more potent efficacy over sorafenib or sunitinib in renal cell carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Pfizer
• Treatments: Axitinib; Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmation of RCC without a clear cell histologic component, e.g., papillary type, chromophobe type, medullary type or unclassified)

• Patients with stage IV or recurrent disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent

• Previous treatment with temsirolimus

• Measurable disease according to RECIST criteria

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• Age 18 years or older

• Adequate cardiac function

• Adequate bone marrow, hepatic, and renal function

• Hematology:

Neutrophil same or more than 1.5 x 10^9/L Platelet same or more than 75 x 10^9/L Hemoglobin same or more than 9 g/dL -Liver function tests: Total bilirubin same or less than 1.5 x upper limit normal (xULN) aspartate aminotransferase(AST), alanine aminotransferase (ALT) same or less than 2.5 xULN Alkaline phosphatase same or less than 2.5 xULN

-Renal function tests: Creatinine clearance same or more than 30 mL/min

• Life expectancy more than 3 months

• Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment

Exclusion Criteria:

• Clear cell type RCC

• Composed of mostly sarcomatoid carcinoma

• Collecting duct type RCC

• Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri

• Hypertension that cannot be controlled by medications (blood pressure 150/90 mmHg despite optimal medical therapy)

• Pregnancy or breast feeding

• Other severe acute or chronic medical or psychiatric condition

• Prior treatment on sunitinib, sorafenib, pazopanib or bevacizumab

• Uncontrolled central nerve system (CNS) metastasis (brain and/or leptomeningeal metastasis)

• Patients who require concomitant treatment with potent cytochrome P 3A4 ( CYP3A4) inducers and inhibitors